scholarly journals 443. Pre-vaccination Antibody Titers Against Seasonal Coronaviruses And Antibody Responses to the Pfizer-BioNTech BNT162b2 COVID-19 mRNA Vaccine in Healthcare Workers

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S323-S323
Author(s):  
Eric Laing ◽  
Si’Ana Coggins ◽  
Kevin Schully ◽  
Emily Samuels ◽  
Emilie Goguet ◽  
...  
Keyword(s):  
Healthcare Workers ◽  
Vaccine Trial ◽  
Antibody Responses ◽  
Spike Protein ◽  
Phase Iii ◽  
P Value ◽  
Material Support ◽  
Pearson's R ◽  
Antibody Titers ◽  
R Value

Abstract Background The Prospective Assessment of SARS-CoV-2 Seroconversion (PASS) study is following over 200 healthcare workers who have received the Pfizer-BioNTech BNT162b2 COVID-19 mRNA vaccine. A major aim of the study is to determine whether baseline antibody titers against the seasonal human coronaviruses are associated with altered levels of vaccine-induced antibody responses to SARS-CoV-2. Methods Serial serum samples obtained pre-vaccination and 1 month after the second dose were tested for IgG antibodies against the full pre-fusion spike protein and the receptor binding domain (RBD) of SARS-CoV-2, as well as the full pre-fusion spike proteins of OC43, HKU1, 229E, and NL63. Antibodies were measured using highly sensitive and specific multiplex assays based on Luminex-xMAP technology. Results Preliminary analyses of the first 103 subjects in whom we have 1 month post-vaccination serum demonstrate development of high IgG geometric mean titers (GMT) to both the full spike protein (GMT: 13,685, 12,014-15,589, 95% CI) and the RBD (GMT: 19,448, 17,264-21,908, 95% CI) of SARS-CoV-2 after the 2nd vaccine dose. Preliminary analysis demonstrates no association between baseline antibody titers against spike protein of OC43 and antibody titers against SARS-CoV-2 spike protein (Pearson’s r-value= 0.13, P-value= 0.21) or RBD (Pearson’s r-value= 0.09, P-value= 0.36) one month after vaccination. Future analyses will evaluate whether there is an association with baseline seasonal coronavirus antibody titers and either SARS-CoV-2 neutralization titers or anti-SARS-CoV-2 spike protein titers at 6 months after vaccination. Conclusion These preliminary results suggest that baseline antibody responses to seasonal coronaviruses neither boost nor impede SARS-CoV-2 vaccine-induced antibody responses. Longitudinal sampling will enable assessment of vaccine durability and determination of whether baseline seasonal coronavirus antibody levels are associated with altered duration of detectable COVID-19 vaccine-induced antibody responses. Disclosures Simon Pollett, MBBS, Astra Zeneca (Other Financial or Material Support, HJF, in support of USU IDCRP, funded under a CRADA to augment the conduct of an unrelated Phase III COVID-19 vaccine trial sponsored by AstraZeneca as part of USG response (unrelated work)) David Tribble, M.D., DrPH, Astra Zeneca (Other Financial or Material Support, HJF, in support of USU IDCRP, funded under a CRADA to augment the conduct of an unrelated Phase III COVID-19 vaccine trial sponsored by AstraZeneca as part of USG response (unrelated work))

scholarly journals Immunological features that determine the strength of antibody responses to BNT162b2 mRNA vaccine against SARS-CoV-2

2021 ◽  
Author(s):  
Takahiro Kageyama ◽  
Shigeru Tanaka ◽  
Keishi Etori ◽  
Koto Hattori ◽  
Kazusa Miyachi ◽  
...  
Keyword(s):  
T Cells ◽  
Antibody Titer ◽  
Cd8 T Cells ◽  
Healthcare Workers ◽  
Mononuclear Cells ◽  
Antibody Responses ◽  
Peripheral Blood Mononuclear ◽  
Transitional B Cells ◽  
Blood Mononuclear Cells ◽  
Antibody Titers

We analyzed peripheral blood mononuclear cells (PBMCs) of each 20 individuals with a high anti-SARS-CoV-2 antibody titer and a low antibody titer out of 1,774 healthcare workers who received BNT162b2 mRNA vaccine. A higher antibody titer was associated with the frequencies of naive and transitional B cells before vaccination. In addition, fold changes in the frequency of activated CD8+ T cells upon vaccination were correlated with the antibody titers.

scholarly journals 337. SARS-CoV-2 Viral Load Does Not Predict Incident Venous Thromboembolism in COVID-19

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S273-S273
Author(s):  
Simon Pollett ◽  
Benjamin Wier ◽  
Stephanie A Richard ◽  
Anthony C Fries ◽  
Ryan C Maves ◽  
...  
Keyword(s):  
Logistic Regression ◽  
Viral Load ◽  
Venous Thromboembolism ◽  
Vaccine Trial ◽  
Panel Member ◽  
Phase Iii ◽  
Review Panel ◽  
Military Health ◽  
Material Support ◽  
Icd 10

Abstract Background The risk factors of venous thromboembolism (VTE) in COVID-19 warrant further study. We leveraged a cohort in the Military Health System (MHS) to identify clinical and virological predictors of incident deep venous thrombosis (DVT), pulmonary embolism (PE), and other VTE within 90-days after COVID-19 onset. Methods PCR or serologically-confirmed SARS-CoV-2 infected MHS beneficiaries were enrolled via nine military treatment facilities (MTF) through April 2021. Case characteristics were derived from interview and review of the electronic medical record (EMR) through one-year follow-up in outpatients and inpatients. qPCR was performed on upper respiratory swab specimens collected post-enrollment to estimate SARS-CoV-2 viral load. The frequency of incident DVT, PE, or other VTE by 90-days post-COVID-19 onset were ascertained by ICD-10 code. Correlates of 90-day VTE were determined through multivariate logistic regression, including age and sampling-time-adjusted log10-SARS-CoV-2 GE/reaction as a priori predictors in addition to other demographic and clinical covariates which were selected through stepwise regression. Results 1473 participants with SARS-CoV-2 infection were enrolled through April 2021. 21% of study participants were inpatients; the mean age was 41 years (SD = 17.0 years). The median Charlson Comorbidity Index score was 0 (IQR = 0 - 1, range = 0 - 13). 27 (1.8%) had a prior history of VTE. Mean maximum viral load observed was 1.65 x 107 genome equivalents/reaction. 36 (2.4%) of all SARS-CoV-2 cases (including inpatients and outpatients), 29 (9.5%) of COVID-19 inpatients, and 7 (0.6%) of outpatients received an ICD-10 diagnosis of any VTE within 90 days after COVID-19 onset. Logistic regression identified hospitalization (aOR = 11.1, p = 0.003) and prior VTE (aOR = 6.2 , p = 0.009) as independent predictors of VTE within 90 days of symptom onset. Neither age (aOR = 1.0, p = 0.50), other demographic covariates, other comorbidities, nor SARS-CoV-2 viral load (aOR = 1.1, p = 0.60) were associated with 90-day VTE. Conclusion VTE was relatively frequent in this MHS cohort. SARS-CoV-2 viral load did not increase the odds of 90-day VTE. Rather, being hospitalized for SARS-CoV-2 and prior VTE history remained the strongest predictors of this complication. Disclosures Simon Pollett, MBBS, Astra Zeneca (Other Financial or Material Support, HJF, in support of USU IDCRP, funded under a CRADA to augment the conduct of an unrelated Phase III COVID-19 vaccine trial sponsored by AstraZeneca as part of USG response (unrelated work)) Ryan C. Maves, MD, EMD Serono (Advisor or Review Panel member)Heron Therapeutics (Advisor or Review Panel member) David A. Lindholm, MD, American Board of Internal Medicine (Individual(s) Involved: Self): Member of Auxiliary R&D Infectious Disease Item-Writer Task Force. No financial support received. No exam questions will be disclosed ., Other Financial or Material Support David Tribble, M.D., DrPH, Astra Zeneca (Other Financial or Material Support, HJF, in support of USU IDCRP, funded under a CRADA to augment the conduct of an unrelated Phase III COVID-19 vaccine trial sponsored by AstraZeneca as part of USG response (unrelated work))

scholarly journals 450. Type I Interferon Autoantibodies Are Detected in Those with Critical COVID-19, Including a Young Female Patient

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S325-S326
Author(s):  
Debra Yee ◽  
Marana Tso ◽  
Elana Shaw ◽  
Lindsey B Rosen ◽  
Emily Samuels ◽  
...  
Keyword(s):  
High Throughput Screening ◽  
Task Force ◽  
Vaccine Trial ◽  
High Flow ◽  
Immune Defense ◽  
Phase Iii ◽  
Type I ◽  
Type I Ifn ◽  
Material Support ◽  
High Flow Oxygen

Abstract Background Approximately 10-20% of patients with critical COVID-19 harbor neutralizing autoantibodies (auto-Abs) that target type I interferons (IFN), a family of cytokines that induce critical innate immune defense mechanisms upon viral infection. Studies to date indicate that these auto-Abs are mostly detected in men over age 65. Methods We screened for type I IFN serum auto-Abs in sera collected < 21 days post-symptom onset in a subset of 103 COVID-19 inpatients and 24 outpatients drawn from a large prospective cohort study of SARS-CoV-2 infected patients enrolled across U.S. Military Treatment Facilities. The mean age of this n = 127 subset of study participants was 55.2 years (SD = 15.2 years, range 7.7 – 86.2 years), and 86/127 (67.7%) were male. Results Among those hospitalized 49/103 (47.6%) had severe COVID-19 (required at least high flow oxygen), and nine subjects died. We detected neutralizing auto-Abs against IFN-α, IFN-ω, or both, in four inpatients (3.9%, 8.2% of severe cases), with no auto-Abs detected in outpatients. Three of these patients were white males over the age of 62, all with multiple comorbidities; two of whom died and the third requiring high flow oxygen therapy. The fourth patient was a 36-year-old Hispanic female with a history of obesity who required mechanical ventilation during her admission for COVID-19. Conclusion These findings support the association between type I IFN auto-antibody production and life-threatening COVID-19. With further validation, reliable high-throughput screening for type I IFN auto-Abs may inform diagnosis, pathogenesis and treatment strategies for COVID-19, particularly in older males. Our finding of type I IFN auto-Ab production in a younger female prompts further study of this autoimmune phenotype in a broader population. Disclosures David A. Lindholm, MD, American Board of Internal Medicine (Individual(s) Involved: Self): Member of Auxiliary R&D Infectious Disease Item-Writer Task Force. No financial support received. No exam questions will be disclosed ., Other Financial or Material Support David Tribble, M.D., DrPH, Astra Zeneca (Other Financial or Material Support, HJF, in support of USU IDCRP, funded under a CRADA to augment the conduct of an unrelated Phase III COVID-19 vaccine trial sponsored by AstraZeneca as part of USG response (unrelated work)) Simon Pollett, MBBS, Astra Zeneca (Other Financial or Material Support, HJF, in support of USU IDCRP, funded under a CRADA to augment the conduct of an unrelated Phase III COVID-19 vaccine trial sponsored by AstraZeneca as part of USG response (unrelated work))

scholarly journals Variable loss of antibody potency against SARS-CoV-2 B.1.1.529 (Omicron)

2021 ◽  
Author(s):  
Daniel J. Sheward ◽  
Changil Kim ◽  
Roy A. Ehling ◽  
Alec Pankow ◽  
Xaquin Castro Dopico ◽  
...  
Keyword(s):  
Healthcare Workers ◽  
Blood Donors ◽  
Neutralizing Antibody ◽  
Neutralization Assay ◽  
Antibody Responses ◽  
Pseudotyped Virus ◽  
Virus Neutralization Assay ◽  
Form Part ◽  
Antibody Titers ◽  
Cross Neutralization

The recently-emerged SARS-CoV-2 B.1.1.529 variant (Omicron) is spreading rapidly in many countries, with a spike that is highly diverged from the pandemic founder, raising fears that it may evade neutralizing antibody responses. We cloned the Omicron spike from a diagnostic sample which allowed us to rapidly establish an Omicron pseudotyped virus neutralization assay, sharing initial neutralization results only 13 days after the variant was first reported to the WHO, 8 days after receiving the sample. Here we show that Omicron is substantially resistant to neutralization by several monoclonal antibodies that form part of clinical cocktails. Further, we find neutralizing antibody responses in pooled reference sera sampled shortly after infection or vaccination are substantially less potent against Omicron, with neutralizing antibody titers reduced by up to 45 fold compared to those for the pandemic founder. Similarly, in a cohort of convalescent sera prior to vaccination, neutralization of Omicron was low to undetectable. However, in recent samples from two cohorts from Stockholm, Sweden, antibody responses capable of cross-neutralizing Omicron were prevalent. Sera from infected-then-vaccinated healthcare workers exhibited robust cross-neutralization of Omicron, with an average potency reduction of only 5-fold relative to the pandemic founder variant, and some donors showing no loss at all. A similar pattern was observed in randomly sampled recent blood donors, with an average 7-fold loss of potency. Both cohorts showed substantial between-donor heterogeneity in their ability to neutralize Omicron. Together, these data highlight the extensive but incomplete evasion of neutralizing antibody responses by the Omicron variant, and suggest that increasing the magnitude of neutralizing antibody responses by boosting with unmodified vaccines may suffice to raise titers to levels that are protective.

scholarly journals Effect of Belimumab on Vaccine Antigen Antibodies to Influenza, Pneumococcal, and Tetanus Vaccines in Patients with Systemic Lupus Erythematosus in the BLISS-76 Trial

2012 ◽  
Vol 39 (8) ◽  
pp. 1632-1640 ◽  
Author(s):  
W. WINN CHATHAM ◽  
DANIEL J. WALLACE ◽  
WILLIAM STOHL ◽  
KEVIN M. LATINIS ◽  
SUSAN MANZI ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Influenza Vaccine ◽  
Lupus Erythematosus ◽  
Antibody Responses ◽  
Phase Iii ◽  
Systemic Lupus ◽  
Live Virus ◽  
Number Of Patients ◽  
Antibody Titers ◽  
Antibody Levels

Objective.In patients with systemic lupus erythematosus (SLE), evidence suggests that most vaccines (except live-virus vaccines) are safe, although antibody response may be reduced. This substudy from the phase III, randomized, double-blind, placebo-controlled BLISS-76 trial evaluated the effects of belimumab on preexisting antibody levels against pneumococcal, tetanus, and influenza antigens in patients with SLE.Methods.In BLISS-76, patients with autoantibody-positive, active SLE were treated with placebo or belimumab 1 or 10 mg/kg every 2 weeks for 28 days and every 28 days thereafter, plus standard SLE therapy, for 76 weeks. This analysis included a subset of patients who had received pneumococcal or tetanus vaccine within 5 years or influenza vaccine within 1 year of study participation. Antibodies to vaccine antigens were tested at baseline and Week 52, and percentage changes in antibody levels from baseline and proportions of patients maintaining levels at Week 52 were assessed. Antibody titers were also assessed in a small number of patients vaccinated during the study.Results.Consistent with preservation of the memory B cell compartment with belimumab treatment, the proportions of patients maintaining antibody responses to pneumococcal, tetanus, and influenza antigens were not reduced. In a small group receiving influenza vaccine on study, antibody responses were frequently lower with belimumab, although titer levels were > 1:10 in all patients treated with 10 mg/kg and in the majority treated with 1 mg/kg.Conclusion.Treatment with belimumab did not affect the ability of patients with SLE to maintain antibody titers to previous pneumococcal, tetanus, and influenza immunizations. [ClinicalTrials.gov registration number NCT 00410384]

scholarly journals Emergency Response for Evaluating SARS-CoV-2 Immune Status, Seroprevalence and Convalescent Plasma in Argentina

2020 ◽  
Author(s):  
Diego S. Ojeda ◽  
María Mora Gonzalez Lopez Ledesma ◽  
Horacio Pallares ◽  
Guadalupe S. Costa Navarro ◽  
Lautaro Sanchez ◽  
...  
Keyword(s):  
Health Care ◽  
Immune Responses ◽  
Health Care Workers ◽  
Antibody Responses ◽  
Spike Protein ◽  
Receptor Binding Domain ◽  
Care Workers ◽  
Antibody Titers ◽  
Health Institutions ◽  
Antibody Levels

ABSTRACTWe report the emergency development and application of a robust serologic test to evaluate acute and convalescent antibody responses to SARS-CoV-2 in Argentina. The assays, COVIDAR IgG and IgM, which were produced and provided for free to health authorities, private and public health institutions and nursing homes, use a combination of a trimer stabilized spike protein and the receptor binding domain (RBD) in a single enzyme-linked immunosorbent assay (ELISA) plate. Over half million tests have already been distributed to detect and quantify antibodies for multiple purposes, including assessment of immune responses in hospitalized patients and large seroprevalence studies in neighborhoods, slums and health care workers, which resulted in a powerful tool for asymptomatic detection and policy making in the country. Analysis of antibody levels and longitudinal studies of symptomatic and asymptomatic SARS-CoV-2 infections in over one thousand patient samples provided insightful information about IgM and IgG seroconversion time and kinetics, and IgM waning profiles. At least 35% of patients showed seroconversion within 7 days, and 95% within 45 days of symptoms onset, with simultaneous or close sequential IgM and IgG detection. Longitudinal studies of asymptomatic cases showed a wide range of antibody responses with median levels below those observed in symptomatic patients. Regarding convalescent plasma applications, a protocol was standardized for the assessment of end point IgG antibody titers with COVIDAR with more than 500 plasma donors. The protocol showed a positive correlation with neutralizing antibody titers, and was used to assess antibody titers for clinical trials and therapies across the country. Here, we demonstrate the importance of providing a robust and specific serologic assay for generating new information about antibody kinetics in infected individuals and mitigation policies to cope with pandemic needs.AUTHOR SUMMARYThe development of robust and specific serologic assays to detect antibodies to SARS-CoV-2 is essential to understand the pandemic evolution and to stablish mitigation strategies. Here, we report the emergency development, production and application of a versatile ELISA test for detecting antibodies against the whole spike protein and its receptor binding domain. Over half million tests have been freely distributed in public and private health institutions of Argentina for evaluating immune responses, convalescent plasma programs and for large seroprevalence studies in neighborhoods and health care workers. We are still learning how and when to use serologic testing in different epidemiological settings. This program allowed us to produce large amount of high quality data on antibody levels in symptomatic and asymptomatic SARS-CoV-2 infections and generate relevant information about IgM and IgG seroconversion time and kinetics. We also present standardized protocols for antibody quantification as guidance for convalescent donor plasma selection in hospitals throughout the country for compassionate use and clinical trials. Here, we provide a framework for generating widely available tools, protocols and information of antibody responses for pandemic management.

scholarly journals Seroprevalence of SARS-CoV-2 IgG antibodies, in Corsica (France), April and June 2020.

2020 ◽  
Author(s):  
Lisandru Capai ◽  
Nazli Ayhan ◽  
Shirley Masse ◽  
Jean Canarelli ◽  
Stephane Priet ◽  
...  
Keyword(s):  
Neutralization Test ◽  
Age Groups ◽  
Neutralizing Antibody ◽  
Blood Analysis ◽  
Spike Protein ◽  
P Value ◽  
Igg Antibodies ◽  
Antibody Titers ◽  
The Impact ◽  
Sera Samples

Our aim was to assess the seroprevalence of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection after the lockdown in a sample of the Corsican population. Between 16th April and 15th June 2020, 2,312 residual sera were collected from patients having carried out a blood analysis in one of the participating laboratories. Residual sera obtained from persons of all ages were tested for the presence of anti-SARS-CoV-2 IgG using the EUROIMMUN enzyme immunoassay kit for semiquantitative detection of IgG antibodies against S1 domain of viral spike protein (ELISA-S). Borderline and positive samples in ELISA-S were also tested with an in-house virus neutralization test (VNT). Prevalence values were adjusted for sex and age. A total of 1,973 residual sera samples were included in the study. The overall seroprevalence based on ELISA-S was 5.27% [95% confidence interval (CI) 4.33-6.35] and 5.46% [4.51-6.57] after adjustment. Gender was not associated with IgG detection. However, significant differences were observed between age groups (p-value = 1 E-5) and particularly for people being younger than 50 years of age (Odd ratio (OR) = 2.86 95% CI [1.80- 4.53]; p-value <0.000001*). The prevalence of neutralizing antibody titers ≥40 was of 3% [2.28-3.84]. In conclusion the present study showed that a low seroprevalence for COVID-19 in Corsica in accordance with values reported for other French regions in which the impact of the pandemic was low.

scholarly journals Evaluation of Antibody Responses to COVID-19 Vaccines among Solid Tumor and Hematologic Patients

Cancers ◽  
2021 ◽  
Vol 13 (17) ◽  
pp. 4312
Author(s):  
Josef Singer ◽  
Nguyen-Son Le ◽  
Daniel Mattes ◽  
Valerie Klamminger ◽  
Klaus Hackner ◽  
...  
Keyword(s):  
Solid Tumor ◽  
Antibody Responses ◽  
University Hospital ◽  
Spike Protein ◽  
Vulnerable Patients ◽  
Health Strategy ◽  
Antibody Titers ◽  
The University ◽  
The Impact

Vaccination is the primary public health strategy to cope with the COVID-19 pandemic. Although solid tumor and hematologic patients are at higher risk of serious COVID-19-related complications, data on immune responses to COVID-19 vaccines in this patient cohort are particularly scarce. The present study, therefore, aimed at the standardized determination of anti-SARS-CoV-2 spike protein antibody titers among non-vaccinated versus vaccinated solid tumor and hematologic patients who are under clinical observation or under treatment at the University Hospital Krems. Standardized anti-SARS-CoV-2 S antibody titers of a total of 441 patients were retrospectively analyzed. Our results show that antibody titers against the SARS-CoV-2 spike protein are significantly higher in solid tumor versus hematologic patients. While SARS-CoV-2 antibody titers were equal among sexes, an age-dependent decrease was observed. Of note, our studies additionally show that complete vaccination represents a valuable predictor for high anti-SARS-CoV-2 antibody responses in solid tumor and hematologic patients. In summary, to date, this is one of the largest studies to comprehensively evaluate the impact of various COVID-19 vaccines on anti-SARS-CoV-2 S antibody production in solid tumor and hematologic patients. Our findings aim to support future vaccination strategies in these highly vulnerable patients, including vaccination booster programs and alternative protective approaches.

scholarly journals Serological assessment of SARS-CoV-2 infection during the first wave of the pandemic in Louisville Kentucky

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Krystal T. Hamorsky ◽  
Adrienne M. Bushau-Sprinkle ◽  
Kathleen Kitterman ◽  
Julia M. Corman ◽  
Jennifer DeMarco ◽  
...  
Keyword(s):  
Immune Response ◽  
Sensitivity And Specificity ◽  
Immunosorbent Assay ◽  
Receptor Binding ◽  
Healthcare Workers ◽  
Antibody Responses ◽  
Enzyme Linked Immunosorbent Assay ◽  
Receptor Binding Domain ◽  
Iga Antibodies ◽  
Antibody Titers

AbstractSerological assays intended for diagnosis, sero-epidemiologic assessment, and measurement of protective antibody titers upon infection or vaccination are essential for managing the SARS-CoV-2 pandemic. Serological assays measuring the antibody responses against SARS-CoV-2 antigens are readily available. However, some lack appropriate characteristics to accurately measure SARS-CoV-2 antibodies titers and neutralization. We developed an Enzyme-linked Immunosorbent Assay (ELISA) methods for measuring IgG, IgA, and IgM responses to SARS-CoV-2, Spike (S), receptor binding domain (RBD), and nucleocapsid (N) proteins. Performance characteristics of sensitivity and specificity have been defined. ELISA results show positive correlation with microneutralization and Plaque Reduction Neutralization assays with infectious SARS-CoV-2. Our ELISA was used to screen healthcare workers in Louisville, KY during the first wave of the local pandemic in the months of May and July 2020. We found a seropositive rate of approximately 1.4% and 2.3%, respectively. Our analyses demonstrate a broad immune response among individuals and suggest some non-RBD specific S IgG and IgA antibodies neutralize SARS-CoV-2.

scholarly journals 7. Can Recombinant Zoster Vaccine Administration Decrease the Use of Herpes Zoster-related Pain Medication Across Randomized Controlled Studies?

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S3-S4
Author(s):  
Joon Hyung Kim ◽  
Robert Johnson ◽  
Martina Kovac ◽  
Anthony L Cunningham ◽  
Srikanth Emmadi ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Herpes Zoster ◽  
Pain Medication ◽  
Phase Iii ◽  
P Value ◽  
Zoster Vaccine ◽  
Material Support ◽  
Recombinant Zoster Vaccine ◽  
Clinically Significant

Abstract Background Older and immunocompromised adults are at increased risk for herpes zoster (HZ) and often experience persistent, severe HZ-related pain, impacting their quality of life and activities of daily living. High vaccine efficacy (VE) of the adjuvanted recombinant zoster vaccine (RZV) in preventing HZ and reducing severe and clinically significant HZ-related pain has been shown in adults ≥ 50 years of age (YOA; ZOE-50 study; NCT01165177), ≥ 70 YOA (ZOE-70; NCT01165229) and ≥ 18 YOA undergoing autologous hematopoietic stem cell transplantation (ZOE-HSCT; NCT01610414). Methods In patients with confirmed HZ from the above phase III, randomized, placebo-controlled studies, we analyzed VE of RZV in reducing the duration of clinically significant HZ-related pain and in reducing the use and duration of HZ-related pain medication. Pain was assessed by the Zoster Brief Pain Inventory (ZBPI). Use of all HZ-related medication was recorded. Results VE in reducing the duration of clinically significant HZ-related pain (ZBPI pain score ≥3) during HZ episodes was 38.5% (p-value: 0.0099) in RZV-vaccinated patients from the ZOE-HSCT study compared to placebo. A similar trend (not statistically significant) was observed in the ZOE-50 (VE: 26.9%; p-value: 0.4318) and ZOE-70 (VE: 28.4%; p-value: 0.1877) studies. VE in reducing the use (Table 1) and duration (Table 2) of HZ-related pain medication was 39.6% (p-value: 0.0083) and 49.3%(p-value: 0.0404), respectively, in the ZOE-70 study; corresponding positive VE estimates were also seen in the ZOE-50 and ZOE-HSCT studies. Non-opioids were used by 61.2%, 44.3% and 22.1% of patients in the ZOE-50, ZOE-70 and ZOE-HSCT studies, respectively; weak opioids by 18.6%, 13.0% and 10.8% of patients, and strong opioids by 8.0%, 2.0% and 5.3% of patients (Table 3). Table 1. Reduction in the use of HZ-related pain medication in patients with confirmed HZ Table 2. Reduction in the duration of HZ-related pain medication use in patients with confirmed HZ Table 3. HZ-related medication types in patients with confirmed HZ Conclusion In addition to a high VE in preventing HZ in these studies, we also observed an attenuation of HZ-related pain, and thus lower use and duration of pain medication in breakthrough cases after RZV vaccination, thereby potentially improving patient quality of life. Funding: GlaxoSmithKline Biologicals SA Acknowledgment: Kristel Vercauteren/Sander Hulsmans (Modis c/o GSK) provided medical writing/editorial support Disclosures Joon Hyung Kim, MD, GSK (Employee, Shareholder) Robert Johnson, MD, FRCA, GSK (Other Financial or Material Support, I accept no fees but have had expense reimbursement in the past.) Martina Kovac, MD, GSK (Other Financial or Material Support, I was an employee of GSK at the time of the study) Anthony L. Cunningham, MBBS, MD, FRACP, FRCPA, GSK (Consultant) Srikanth Emmadi, MSc, GSK (Employee) Keith Sullivan, MD, FASTCT, GSK (Consultant) Alemnew F. Dagnew, MD, GSK group of companies (Employee, Shareholder) Desmond Curran, PhD, GSK (Employee, Shareholder) Anne Schuind, MD, GSK (Employee, Other Financial or Material Support, own GSK stock options or restricted shares as part of renumeration)

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